Medtronic Lead Lawsuit

On October 15, 2007, Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation leads. Medtronic announced that the recall was due to “the potential for lead fractures.” At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads. The Food and Drug Administration classified the recall as “Class 1,” which is the most serious type of recall and involve situations where there is a reasonable probability that the use of the product will cause serious injury or death.

Implantable cardioverter-defibrillators (ICDs) are being used with greater frequency in the treatment of children with congenital heart abnormalities and other life threatening ventricular arrhythmia heart problems. Children are at much greater risk of having one of the recalled Medtronic leads fracture because they are more physically active and due to growth issues. A fractured lead that results in inappropriate shocks can have significant psychological and emotional effects especially the younger the age of the child.

Studies have shown that children receiving an inappropriate shock from their defibrillator were associated with reduced mental wellbeing and physical functioning. Receiving an inappropriate shock is the equivalent to being kicked in the chest which can create psychological symptoms even in adult patients.

Some of these symptoms include:

• Anxiety
• Depression
• Excessive worrying
• Problems with family relationships

Pediatric patients differ in several ways and present different complicating factors compared to adult patients. The Heart Rhythm Society relates several of these factors:

“Patients are often smaller than an adult, the anatomy can be more complex, and there may be unique hemodynamic and physiologic consequences of device selection, lead placement and pacing modality. Further, the emotional and psychological support provided may be as important to care delivery as the technical aspects of the procedure.”

The Heart Rhythm Society goes on and states that these issues are even more important for children under the age of thirteen. The Medtronic Recall of their Sprint Fidelis leads has been even more critical for children with an ICD due to the serious issues involved with removing the leads during an explant surgery.

By: John Humphrey

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David Johnson is author of this article on Medtronics recall. Find more information about Medtronics lawsuit here.